FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
K Number: K100610
·
Decision Jan 20, 2011
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
32
Applicant Total
19
Review Days
323
Basic Information
- Device Name
- LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
- K Number
- K100610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LUTRONIC CORPORATION
- Date Received
- March 3, 2010
- Decision Date
- January 20, 2011
- Product Code
- ONG
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K113668 | HEALITE II SYSTEM | Jun 19, 2012 | Substantially Equivalent |
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| K113588 | SPECTRA LASER SYSTEM | Feb 22, 2012 | Substantially Equivalent |
| K103455 | SPECTRA LASER SYSTEM | Apr 28, 2011 | Substantially Equivalent |
| K101573 | ACCUSCULPT II LASER SYSTEM | Sep 23, 2010 | Substantially Equivalent |